Epithalon

Epithalon (also spelled Epitalon) was designed by Vladimir Khavinson's St. Petersburg Institute of Bioregulation and Gerontology from the amino-acid makeup of epithalamin, a cattle pineal-gland extract. FDA treats Epithalon and the epithalamin extract as different substances.

FDA calls the mechanism unknown. In cell studies it switched on telomerase and lengthened telomeres in human fibroblasts, and a 2025 UK study saw telomere lengthening in normal cells and, by a different pathway, in two breast-cancer lines. It raised evening melatonin in aged monkeys but did not raise melatonin release in a rat pineal preparation.

Almost all research comes from one St. Petersburg institute. The well-known telomere and longer-life claims come from cell and mouse studies; the human longevity studies tested the older epithalamin extract, not this peptide. The only randomized study of Epithalon itself found a rise in a urinary melatonin marker in 40 women, without clinical outcomes or safety data. Female mice given it throughout life were reported to live longer with fewer tumors, but one study in a cancer-prone mouse strain found shortened maximum lifespan in some study groups. Human pharmacokinetics, toxicology and independent replication are all missing.

Side effects have not been characterized; developer claims of 'no side effects' could not be verified by FDA. FDA flagged a theoretical cancer concern because the claimed mechanism is telomerase activation, plus immunogenicity and poorly characterized material. No reproductive or carcinogenicity studies exist.

Not FDA-approved and not approved as a drug in any country FDA checked. FDA staff recommended against 503A listing, but in July 2026 its Pharmacy Compounding Advisory Committee voted 7–4–1 to recommend adding it (as Epitalon) to the 503A bulks list for insomnia; the vote is advisory, FDA had issued no final rule as of October 2026, and it concerns pharmacy compounding for patients, not research-grade material. Not named on the 2026 WADA List but falls under S0 (non-approved substances), prohibited at all times. An FDA orphan designation for retinitis pigmentosa (2010) was withdrawn in 2016.